A U.S. panel deliberated over how to allocate limited doses of COVID-19 vaccines. |
The first available doses in the U.S. of vaccines to protect against COVID-19 should be allocated to healthcare workers and residents and staff of long-term care facilities, an outside advisory committee to the Centers for Disease Control and Prevention said.
The CDC's Advisory Committee on Immunization Practices, or ACIP, voted 13 to 1 that those two groups of Americans, which comprise about 24 million people, should be prioritized to get the limited doses of COVID-19 vaccines if and when the Food and Drug Administration clears the products for the U.S. market — a decision that could come as early as the week of Dec. 7.
The ACIP did not review specific vaccines at the Dec. 1 emergency meeting but debated only the question of whether healthcare personnel and people at long-term care facilities — residents and workers at nursing homes and assisted-living facilities — should be first in line during the U.S. phased-in rollout for the vaccines.
Amanda Cohn, CDC's executive secretariat for the ACIP and acting chief medical officer for the agency's National Center for Immunization and Respiratory Diseases, said the committee will meet again on whether to recommend a specific COVID-19 vaccine after the FDA authorizes a product.
The FDA's Vaccines and Related Biological Products Advisory Committee, or VRBPAC, is scheduled to review an emergency use authorization, or EUA, application from Pfizer Inc. and BioNTech SE on Dec. 10. The FDA could act within days or even hours after the VRBPAC meets, according to Moncef Slaoui, chief scientific adviser for the White House's Operation Warp Speed.
The U.S. government has signed six contracts to buy hundreds of millions of doses of COVID-19 vaccines. But only about 40 million of the shots are expected to be available by the end of December — 20 million from Pfizer and BioNTech and 20 million from Moderna Inc., which submitted its EUA application Nov. 30 — Slaoui reiterated during a Dec. 1 online forum hosted by The Washington Post.
The VRBPAC meets Dec. 17 to review Moderna's EUA application.
But the Pfizer-BioNTech and Moderna vaccines require two shots, meaning there will only be enough to vaccinate up to 20 million people in the U.S. by the end of 2020.
There are about 21 million healthcare workers in the U.S. and about 3 million people living in long-term care facilities, CDC officials said at the Dec. 1 ACIP meeting.
Vice President Mike Pence told states Nov. 30 that the vaccine distribution process could start the week of Dec. 14, Ohio Gov. Mike DeWine, a Republican, confirmed Dec. 1 on "CBS This Morning."
The intent of the Dec. 1 emergency ACIP vote was to provide recommendations to state, territorial and local health departments to help guide them in placing their orders for the COVID-19 vaccines, the CDC's Cohn said.
States are facing a Dec. 4 deadline to submit their final COVID-19 vaccine distribution plans to the CDC.
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Ultimately, states will decide which populations in their jurisdictions will get the limited doses, Health and Human Services Secretary Alex Azar told reporters Nov. 24.
Nancy Messonnier, director of the CDC's Center for the National Center for Immunization and Respiratory Diseases, said state and local health departments have signaled they could complete vaccinations for healthcare workers within three weeks.
However, CDC officials urged hospitals to stagger vaccinations for their nurses and doctors to avoid having multiple personnel out from work if they experience adverse events from the shots, which can cause flu-like symptoms.
'Solomon's choice'
Having to decide which groups should be prioritized to get the limited COVID-19 vaccine doses was like "Solomon's choice," said ACIP panelist Peter Szilagyi, a pediatric specialist at UCLA Mattel Children's Hospital in Los Angeles.
But ensuring health workers and long-term care facility residents and staff receive the shots first "represents the right decision," Szilagyi said.
"A nation's greatness is measured by how it treats its weakest members," he said, quoting Indian political activist Mahatma Gandhi.
Helen Talbot, associate professor of medicine at Vanderbilt University — the lone vote against the ACIP's recommendation — said that while she fully backed giving the COVID-19 vaccines first to healthcare workers, she raised concerns about the lack of data in the long-term care facility population.
Vaccines are too often studied in young healthy populations and then "we hope it works in our frail older adults."
The vaccine safety network for long-term care facilities is insufficient and health workers there are not familiar enough with systems for reporting adverse events, Talbot added.
White House pressure
At The Washington Post's Dec. 1 forum, Slaoui acknowledged there will likely not be enough COVID-19 vaccines for the entire U.S. population until June 2021, with the rest of the world likely not fully vaccinated until well into 2022.
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The Warp Speed adviser insisted he was unaware of any tension between FDA and the White House following reports Commissioner Stephen Hahn had been summoned to a Dec. 1 meeting with Mark Meadows, President Donald Trump's chief of staff.
Both Trump and Meadows have accused the FDA without evidence of moving too slowly in getting COVID-19 vaccines to the U.S. market.
White House spokesman Brian Morgenstern confirmed to S&P Global Market Intelligence a report that Trump plans to hold a Dec. 8 event focused on the rollout of COVID-19 vaccines with federal and state government officials and representatives from the private sector, military and the scientific community.
Executives from Pfizer, Moderna, CVS Health Corp., Walgreens Boots Alliance Inc., McKesson Corp., FedEx Corp. and United Parcel Service Inc. have been invited to attend, according to Stat News, which first reported the event.
But some of the executives are "irritated at pressure from the White House to attend an event they perceive to be largely political," Stat reported, citing unnamed sources.